Agreement Checklist: Industry-Initiated Clinical Trials

Office of Sponsored Programs – Industry Support and CTO

Checklist for Initial WIRB Submission

Requirements for submission to Western Institutional Review Board (WIRB) and the Office of Research Subjects Protection (ORSP) along with required forms can be found on the web at http://www.research.vcu.edu/forms/wirb.htm

All initial submissions to WIRB must be delivered to the CTO for billing verification. The CTO will review the WIRB submission and hand carry to ORSP.

Please email informed consent form to for review and approval of subject injury language prior to inclusion with hard copy submission.

All initial submissions must have a total of four (4) copies: 1 for WIRB, 1 for ORSP,,1 for OSP and 1 for CTO.

COPIES FOR WIRB AND ORSP

• WIRB Initial Review Submission Form
• Initial Review Cover Letter
• Protocol (date: ______)
• Amendments (dates for those included: ______)
• Investigator’s Brochure, if applicable (dates for those included: ______)
• Signed FDA Form 1572, if applicable with WIRB listed as the IRB (date: ______)
• Complete grant application, if submitted to a Federal agency.
• Informed consent Form (hard copy) (approved by CTO)

• Informed consent form (CD)
• Advertisements (How many? ______)
• Curriculum Vitae for Principal Investigator and all Sub-Investigators
• DEA and Medical Licenses for Principal Investigator
• Medical Licenses for all Sub-Investigators (if applicable)
• Radiation Safety Committee Approval (if applicable)
• Conflict of Interest Disclosure Statement
• Other documents (______)

• Copies of all of the above

2 COPIES (1 for OSP RED TEAM and 1 for CTO)

 Copy of the Initial Review Submission Form

• Conflict of Interest Disclosure Statement signed by Key Personnel. If there is a conflict, please fill out the Supplement Form. Forms can be found at http://www.research.vcu.edu/oip/ConflictofInterestDisclosureForm.doc

• Email verification from Sponsor stating they will pay fees directly to WIRB along with a billing name and address to send invoices OR if Sponsor will not pay directly provide a Banner Index Code to bill invoices to.

• Executive summary of the protocol (if provided by sponsor, or a copy of the front page of protocol)

• Copy of Informed Consent form (approved by CTO)

PLEASE NOTE: YOUR WIRB SUBMISSION WILL BE DELAYED UNTIL ALL OF THE ABOVE REQUIRED INFORMATION HAS BEEN RECEIVED BY THE CTO